NEW YORK--(BUSINESS WIRE)--Medidata Solutions (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the sponsorship of its first clinical trial, which will evaluate the impact of mobile and cloud-based technology on patient engagement for improved health outcomes in the diabetes community.
By providing patients with the tools they need to track behavioral factors such as weight and physical activity, the pioneering study will test whether technology can increase the rates of therapy adoption and drive better outcomes for people with diabetes. Medidata’s study will use mHealth devices that provide immediate feedback to participants and are wirelessly linked to targeted messaging for unique patient engagement.
The study is in collaboration with Medidata Technology Partner Spaulding Clinical Research, a leading clinical research solution provider and medical device manufacturer, which will use its capabilities to enable the mHealth devices to connect to the Medidata Clinical Cloud™. Withings, a top innovator in health and wellness smart devices and applications, will supply the mHealth devices that will monitor the physical activity and weight of study participants. Leading endocrinologist Dr. Zachary T. Bloomgarden, Clinical Professor of Medicine, Endocrinology, Diabetes and Bone Disease at Mount Sinai Hospital in New York and co-editor of the Journal of Diabetes, is the study’s principal investigator. The initial feasibility stage of the study is slated to start in the fourth quarter of 2013 and will be followed by a randomized clinical trial.
“We are proud to sponsor our first clinical study in collaboration with Spaulding and Withings to see how disruptive technology can improve patient engagement and actually lead to better medical outcomes,” said Glen de Vries, president of Medidata Solutions. “Since our beginning, Medidata has pioneered the use of technology to transform clinical research, and the opportunity to see our technology used to improve patient health in the critical area of diabetes care is a logical—and incredibly exciting—extension.”
More than 20 million Americans have been diagnosed as having diabetes, the number nearly doubling in the past decade due to factors including lack of physical activity and obesity, resulting in significant individual and societal impacts and costs. Through activity monitoring devices, uploaded data and targeted feedback, the Medidata-sponsored study will explore the potential of technology tools to improve overall levels of patient adherence to lifestyle changes. The feedback provided to patients will address exercise levels as well as diet and regular use of recommended medications.
Randy Spaulding, founder and CEO of Spaulding Clinical Research, said, “Wireless and personal mobile devices provide opportunities to improve patient engagement because of their ease of use, real-time transmission of data and increased portability and convenience. This collaboration is an important step in bringing these benefits to the real world.”
“One of the major challenges in diabetes management is working with patients to adopt lifestyle changes,” added Dr. Bloomgarden. “Most diabetics have to live with this chronic condition for a long time, so using personal devices and patient engagement apps to improve quality of life would be very powerful and a huge win for our clinical care models.”
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About Spaulding Clinical Research, LLC
Spaulding Clinical Research, LLC, a change agent in the clinical research and medical device industries, is focused on driving perpetual value for their clients through technology and process innovation that delivers speed, unprecedented quality and lower costs.
Spaulding Clinical Research operates a 135-bed clinical pharmacology unit with 96, 12-lead ECG, telemetry beds in West Bend, Wisconsin, USA. The facility is paperless, using a customized Phase I Electronic Data Capture system with bi-directional interfaces to clinical lab, bedside devices and telemetry. Spaulding Biometrics provides full-service biostatistics, data management and medical writing services.
As a Phase I-IV centralized cardiac safety provider, Spaulding Clinical offers project management, expert cardiologist ECG over-read and a complete suite of state-of-the-art equipment provisioning, including the cloud-based Spaulding webECG™ Management Solution with the purpose-built Spaulding Model 1000iQ Electrocardiograph.
About Withings
Withings is an innovative company that creates smart products and apps to help people across the world easily take care of their health and well-being. Founded by French executives Cedric Hutchings and Eric Carreel, Withings has been pioneering Health 2.0 since the launch of their first Wi-Fi Body Scale in 2009 and is leading the way of the connected health movement. By extending the capabilities of an object through network resources, Withings provides access to infinite computing and storage facility at no extra cost, turning objects into smart connected devices. Since 2009, Withings has extended those benefits to a wide range of lifestyle-friendly devices including the Wi-Fi Body Scale, the Smart Blood Pressure Monitor and the Smart Baby Monitor and the Pulse activity tracker. By using mobile phones and computers as bridges and opening up its platform to the well-being ecosystem, Withings now works seamlessly with over 100 partner apps and devices, providing users with a whole new dimension to their day-to-day life.
About Medidata Solutions
Medidata Solutions is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud™ brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of our global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.
